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Severe Sepsis | Angiotensin II Antagonist in Severe Sepsis

Severe Sepsis research study

What is the primary objective of this study?

The investigators propose a clinical study of irbersartan for the early treatment of severe
sepsis patients with elevated predicted risk of death between. This study will evaluate
whether early administration of the the angiotensin receptor blocker irbersartan provides
significant reduction of 28 days mortality and multi organ failure incidence to patients with
severe sepsis.

Who is eligible to participate?

Inclusion Criteria: adults within 12 hrs of recognition of severe sepsis, with Acute
Physiology and Chronic Health Evaluation (APACHE) II-predicted risk of mortality between
20% and 80% are eligible.
Exclusion Criteria:Patients already treated with ACE inhibitors or ARBs will be excluded.
Patients admitted in shock conditions (systolic blood pressure lower than 90 mmHg) will be
excluded. Patients with severe renal failure (serum creatinine of 2.0 mg/dL or dialysis)
will be excluded.

Study Interventions

Interventions can include giving participants drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available or noninvasive approaches such as surveys, education, and interviews.

Drug:Irbesartan75 mg/per os/for 15 days

Study Arms

Research studies and clinical trials typically have two or more research arms. An arm is a group of people who receive the same treatment in the study.

irbesartanIrbesartan (total dose of 75 mg) or placebo administered every 24 hrs for 15 days. Moreover, the sepsis management will follow standard international guidelines (Crit Care Med.2008 Jan;36(1):296-327. Surviving Sepsis Campaign: international guidelines for management of severe sepsis and septic shock).
Duration of treatment: Irbesartan 75 mg daily for 15 days; only one cycle. Follow up will last 90 days both for treatment and control arm.
Route of administration : oral by nasogastric tube.
Medication permitted and not permitted during the trial:
all the therapeutic interventions for sepsis management as indicated by international guidelines are admitted. During the trial are not permitted: ACE inhibitors, ARBs different from Irbersartan, angiotensin I synthesis inhibitors

PlaceboPackaging and labelling for blinding purposes: tablets of placebo looking like the study drug

Discuss Sepsis

If you think you may have a medical emergency, call your doctor or 911 immediately.

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